The EnGuard compounding isolator provides safe containment and eliminates cross contamination. These isolators are designed primarily for small volume processes including laboratory testing and clinical trial investigations.
EnGuard compounding isolators are single chambers with ergonomic glove port access to areas where operator intervention is required. Process equipment can be removed using a sliding platform which makes maintenance, major changeovers and cleaning all much easier. These isolators can, in some instances, accommodate more than one piece of equipment when the ergonomics and equipment configurations allow.
The EnGuard VTC is designed to provide protection for both product and personnel. Typically, the transfer carts are used to move the aseptically filled vials, with partially seated stoppers, through non-controlled areas providing a class A / class 100 environment during the transport of the products. The EnGuard VTC, which is closed and sealed, will maintain class 100 conditions during storage and transfer of the vials from the parenteral filling lines to the freeze dryer area. The 316L stainless steel interior and exterior provides cleanable surfaces that are finished to pharmaceutical cGMP standards. The interior of the cart features coved corners and surfaces that are 100% cleanable. A special membrane covering protects the HEPA filter. The vial transfer cart environment is HEPA filtered with unidirectional airflow, which can be either re-circulated or exhausted. If exhausted, the airflow passes through a HEPA filter before release. The ergonomic design and airflow pattern provides operator protection during the activity of loading and unloading of stoppered vials.
Several pharmaceutical companies have been cited recently by the FDA for failure to maintain class 100 conditions within transfer carts used to transport stoppered vials.
The EnGuard VTC provides unidirectional airflow across the trays. The airflow is HEPA filtered both entering and exiting the product chamber. The vial transfer cart can be configured to either re-circulate or single pass air. All configurations are modeled and smoke tested, to assure regulatory compliance.
Schaefer Technologies, Inc / EnGuard Systems is your single source supplier for cGMP Sterile Liquid Filling Isolation Systems. Perfect for R&D, Clinical Trials,Pilot Plant and Small Batch Production
Need an ISO Class 5 Hepa Filtered clean room environment in a mini-isolator version to handle those smaller applications? The STI EnGuard Systems Table-Top Isolator is the answer. Designed for smaller pharmacies, physicians, and health care facilities.
• 316L stainless construction • Isolator Hepa Filtered to ISO Class 5 levels • Positive or Negative pressure • Docking station for transporting and introducing potent compounds into the isolator • (2) Piece nitrile gloves for greater flexibility • Customized to Your Specifications • cGMP FEATURES: * Easy to operate. * 316 Stainless steel and poly carbonate panel construction. * FDA approved materials for all product contact surfaces.